Samumed Sm04554 Results Normalized To Baseline

[Throwaway94]

How do you know they can't falsify data for FDA trials? Does the FDA supervise the trials too / audit results?
I recall in that article that the former Samumed employee wrote, he said that it was the highly secretive data/statistics division that was behind the data falsification, and that due to company culture it was impossible to actually audit the raw results.

I will add, that all that talk about data falsification was speculation on that employee's behalf, he never once saw any hard evidence.

Some degree of manipulation is always possible - at the he end of the day the results are just numbers on a spreadsheet and photos in a folder. The FDA approve the trial design and evaluate the raw data + the interpreted results but aren't actively involved while the trial is taking place.

Much like scientific journals, sloppy or dishonest work can still make it through peer review.

 

[MrV88]

From the presentations I've seen, it looks very impressive. But it's another story to translate the lab success to humans.

One thing's for sure, this isn't a Theranos 2.0, they're doing clinical trials and have to show results backed by real tests sooner or later. They also do not fake their studies, if so all of their trials would show great results and they already had 1 trial that failed.

You also need to check your expectations, the results of their hairloss phase II trial are impressive, if their phase III trial shows the same consistent results and comes to market this will be the best news we had in the last 25 years of the hairloss industry.

What do you think about the Alzheimer patient and her treatment?

 

[coolio]

Data can always be fudged to some extent. The FDA isn't looking over everyone's shoulders throughout the trials process.

Samumed is probably not Theranos-level scam. But that isn't saying much.

 

[Throwaway94]

From the presentations I've seen, it looks very impressive. But it's another story to translate the lab success to humans.

One thing's for sure, this isn't a Theranos 2.0, they're doing clinical trials and have to show results backed by real tests sooner or later. They also do not fake their studies, if so all of their trials would show great results and they already had 1 trial that failed.

You also need to check your expectations, the results of their hairloss phase II trial are impressive, if their phase III trial shows the same consistent results and comes to market this will be the best news we had in the last 25 years of the hairloss industry.

I don't think it's a scam outside of the gross hyperbole being employed in his conferences. It's a legitimate biotech company making legitimate products but massively overselling their efficacy outside of trial results.

I 100% agree that when this is approved it's a huge step in the right direction and definitely should be part of the big 4, and gives hope to people who can't tolerate finasteride. It'll be the first FDA approved product in 30 years that actually addresses androgenic hair loss on a mechanistic level (not sold on CB) and with a vastly preferable side effect profile to finasteride.

 

[pegasus2]

People really hyping Samumed again? LOL

Anybody can screen for compounds that modulate pathways known to be involved in disease. Somehow this company found the effective compound no one else found for each of almost every disease known to man. If you buy that I've got a bridge to sell you.

They know good and well that most things don't work out in vivo. They know that most, if not all, of their drugs will fail to show efficacy, yet they make grandiose claims to take half a billion dollars from investors so they can run trials and draw large salaries until people stop giving them money. I hope they will actually hit on something, but it's a lotto ticket and they can't be stupid enough not to know that. It's just supposition, but I think the CEO set this whole operation up as a fundraising scheme, with an outside shot at hitting on something.

 

[frank33]

There's no need to start again with conspirative speculation. We will get the results very soon.
I remind to everyone that rigging a clinical trial is some serious stuff, don't you realize?

 

[trialAcc]

How do you know they can't falsify data for FDA trials? Does the FDA supervise the trials too / audit results?
I recall in that article that the former Samumed employee wrote, he said that it was the highly secretive data/statistics division that was behind the data falsification, and that due to company culture it was impossible to actually audit the raw results.

I will add, that all that talk about data falsification was speculation on that employee's behalf, he never once saw any hard evidence.

Does the FDA audit trial results? Yes.

 

[trialAcc]

People really hyping Samumed again? LOL

Anybody can screen for compounds that modulate pathways known to be involved in disease. Somehow this company found the effective compound no one else found for each of almost every disease known to man. If you buy that I've got a bridge to sell you.

They know good and well that most things don't work out in vivo. They know that most, if not all, of their drugs will fail to show efficacy, yet they make grandiose claims to take half a billion dollars from investors so they can run trials and draw large salaries until people stop giving them money. I hope they will actually hit on something, but it's a lotto ticket and they can't be stupid enough not to know that. It's just supposition, but I think the CEO set this whole operation up as a fundraising scheme, with an outside shot at hitting on something.

Why do you bother with posts like this? I'll take a company with real FDA structured trials underway then the flaming dumpster that is Tsuji begging for funding on twitter.

Either way, the data is literally around the corner, and it's not pre-clinical or pre-human. 675 people were in the upcoming trial and used the product for a year, so we should have a very clear side effect profile and efficacy over a reasonable period. Your distrust of their process/science is already noted, just leave it alone and wait for the data.

 

[pegasus2]

Why do you bother with posts like this? I'll take a company with real FDA structured trials underway then the flaming dumpster that is Tsuji begging for funding on twitter.

Either way, the data is literally around the corner, and it's not pre-clinical or pre-human. 675 people were in the upcoming trial and used the product for a year, so we should have a very clear side effect profile and efficacy over a reasonable period. Your distrust of their process/science is already noted, just leave it alone and wait for the data.

You keep posting the same cope over and over itt, but you get mad at me for reiterating the other side of it. There's no guarantee they will EVER publish the results of the last trial, so just leave it alone and stop getting people's hopes up until they actually release some data that shows it works.

 

[Throwaway99]

When are the latest results due?

 

[trialAcc]

You keep posting the same cope over and over itt, but you get mad at me for reiterating the other side of it. There's no guarantee they will EVER publish the results of the last trial, so just leave it alone and stop getting people's hopes up until they actually release some data that shows it works.

Yes, there is a guarantee they will publish the studies lol. This isn't a phase 1 random trial that will be shelved if dangerous/ineffective. This is the companies current lead pipeline drug and they won't be able to shove the study under the rug somewhere if it fails.

I'm responding to actual posts in here with phase 2 data and saying to wait for the next data set. You come in here with your pre-established biases and just tell everyone it wont work because you say it wont.

 

[blackjack21]

Bizim olmadığımız masa yok.

bunlar tanımamış bizi Androgenetic Alopecia

 

[pegasus2]

Yes, there is a guarantee they will publish the studies lol. This isn't a phase 1 random trial that will be shelved if dangerous/ineffective. This is the companies current lead pipeline drug and they won't be able to shove the study under the rug somewhere if it fails.

I'm responding to actual posts in here with phase 2 data and saying to wait for the next data set. You come in here with your pre-established biases and just tell everyone it wont work because you say it wont.

I don't think you know what pre-established means.

 

[trialAcc]

I don't think you know what pre-established means.

It means you think poorly of the company and science overall and thus think the drug has no potential, regardless of what the data says. If that phase 2 data is continued/sustained over the course of the treatment in phase 3 then this drug is easily comparable if not better then minoxidil, pending safety data. Yet, I've seen you say multiple times that this drug wont come close to minoxodil when we literally have data that shows it could be. That's called bias.

 

[Gegen]

To finish any debate about this until phase 3 results come out :

- Phase 3 trial will bring respectable results as the population treated corresponds to the "optimal" population of the phase 2.

- We don't know the potential of this drug, just see diversity of opinion in previous posts. No need to speculate about this.

 

[Throwaway99]

Do they have a set date? I heard data was to be published in March?

 

[Chads don't bald]

The wnt pathway has been known for a long time. I really doubt the CEO's claim of them being able to cure all this stuff by drugging the wnt pathway.

That being said they have mentioned they have found a novel way to drug the pathway so its possible their treatment is more effective than any previous attempts by other companies.

 

[pegasus2]

The wnt pathway has been known for a long time. I really doubt the CEO's claim of them being able to cure all this stuff by drugging the wnt pathway.

That being said they have mentioned they have found a novel way to drug the pathway so its possible their treatment is more effective than any previous attempts by other companies.

If you had any idea how complex the Wnt pathway is you wouldn't have any hope for this drug. If all it does is inhibit clk then it's not even worth talking about. If it also inhibits GSK3b then it's a useful drug, but no better than the hundred other GSK3b inhibitors.

 

[Isneezedsohard]

They're a private company, just because they're valued at 12 billion doesn't mean they have anything near that, even it terms of potential. I'd also take anything he says with a pinch of salt.

Pegasus was pretty apt with his comparison to Theranos, CEO is making big claims that are likely unsubstantiated. I cannot imagine anyone with a background in cellular/molecular biology is taking anything he says too seriously.

yeah-- f*** this guy. There's no way they've done all those things. It would be f*****g huge news

 

[trialAcc]

yeah-- f*** this guy. There's no way they've done all those things. It would be f*****g huge news

You mean huge news like being one of the biggest biotech start ups in the USA?